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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SYPHILIS (SYPH) SYPHILIS IMMUNOASSAY

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SYPHILIS (SYPH) SYPHILIS IMMUNOASSAY Back to Search Results
Model Number N/A
Device Problems False Negative Result (1225); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, false nonreactive advia centaur xpt syphilis (syph) results when tested with rehydrated blood spot samples. Siemens has completed the investigation. The only available sample types for the testing of blood samples with the advia centaur® syph assay are human serum and plasma (edta, lithium-heparin, sodium-heparin, citrate). The customer has been informed that rehydrated blood spot samples are a non-supported sample type. The instrument has been verified to have no mechanical deficiencies. The instructions for use (ifu) under the specimen collection and handling section states the following: "serum and plasma (edta, lithium heparin, sodium heparin, and citrate) are the recommended sample types for this assay. " the instructions for use (ifu) under the limitations section states the following: "the advia centaur syph assay is limited to the detection of antibodies to t. Pallidum in human serum or plasma (edta, lithium or sodium heparinized plasma, citrated plasma). " the instructions for use (ifu) under the interpretation of results states the following: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings. The assay is performing within specifications. No further evaluation of the device is required.
 
Event Description
Discordant, false nonreactive advia centaur xpt syphilis (syph) repeat results were obtained from a rehydrated blood spot sample after an initial syph reactive result. The nonreactive repeat results were tested with a different rehydrated blood spot sample. The customer performed repeat testing with an alternate rpr (non-treponemal) test method on another rehydrated blood spot sample, resulting reactive. The syph results were not reported to the physician(s). There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, nonreactive advia centaur xpt syphilis (syph) results.
 
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Brand NameADVIA CENTAUR XPT SYPHILIS (SYPH)
Type of DeviceSYPHILIS IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole MA 02032
Manufacturer Contact
stephen perry
333 coney street
east walpole, MA 02032
5086604163
MDR Report Key11933825
MDR Text Key261507987
Report Number1219913-2021-00336
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112343
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2021
Device Model NumberN/A
Device Catalogue Number10492493
Device Lot Number082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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